510(k) · Cleared
ClearedMA012 Aluminum wheelchair, MS019 steel wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sichuan Ast Medical Equipment Co., Ltd. · IOR Wheelchair, Mechanical
Cleared on Aug 15, 2023 as substantially equivalent to K181795 (Sichuan Ast Medical Equipment Co., Ltd., 2018) after a 61-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Aug 15, 2023
- Review
- 61 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935398 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK935398 Tracer Series Manual WheelchairsInvacare Corp. · 1994
- 2 generations backK162621 Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy…Invacare Corporation · 2017
- 1 generation backK181795 AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd. · 2018
- This deviceK231750 MA012 Aluminum wheelchair, MS019 steel wheelchairSichuan Ast Medical Equipment Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK261076 Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair…GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK261075 Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242722 Manual Wheelchair (MASY23)Sichuan Ast Medical Equipment Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · 2026 · cites it directly0descendants
- K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · 2026 · cites it directly0descendants
- K242722Manual Wheelchair (MASY23)Sichuan Ast Medical Equipment Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935398 | Tracer Series Manual Wheelchairs | Invacare Corp. | 1994 | — |
| −2 | K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra… | Invacare Corporation | 2017 | — |
| −1 | K181795 | AST Model MA012 and MS019 Rehab Wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2018 | — |
| 0 (this device) | K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2023 | — |
| +1 | K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026 | — |
| +1 | K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026 | — |
| +1 | K242722 | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IOR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181795 | AST Model MA012 and MS019 Rehab WheelchairSummary page 4…cation name: Mechanical Wheelchair Regulation class: 1 Regulation number: 21CFR 890.3850 Panel: Physical Medicine Product code: IOR IV. Predicate device Primary - K181795 AST Model MA012 and MS019 Rehab Wheelchair Sichuan AST Medical Equipment Co., Ltd V. Device description MA012 A… | 2018 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K261076 (GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K181795.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
What is it indicated for?
MA012 Aluminum wheelchair and MS019 steel wheelchair are intended for medical purpose to provide mobility to persons limited to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231750: MA012 Aluminum wheelchair, MS019 steel wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231750
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026